Transdiagnostic Effects of a Chinese Herbal Formula DEP-2306 on Improving Sleep and Mood in Adults With Depressive Episode With Insufficient Symptoms: A Real-World Study

Abstract

This study aimed to characterize the changes in sleep and mood and assess the safety of a Chinese herbal formula Depression (DEP)-2306 in adults with a depressive episode with insufficient symptoms (DEIS). Additionally, it explored the factors associated with the outcome remission with significant improvement. Between June 2023 and January 2024, 67 DEIS patients were administered daily DEP-2306 over 4 weeks. The main outcomes included depression severity (Patient Health Questionnaire-9 [PHQ-9] and Hamilton depression rating scale [HAMD-17]), anxiety severity (General Anxiety Disorder-7 [GAD-7]), and sleep quality (Pittsburgh Sleep Quality Index [PSQI]). A linear mixed model was used to analyse the score changes, and logistic regression was used to identify factors associated with the outcome remission with significant improvement, which was defined as a PHQ-9 score ≤ 4 and a ≥ 50% reduction from baseline. The results demonstrated that there were significant reductions in PHQ-9 scores from 11.8 to 6.7 (p < 0.01, Cohen's D = 1.55), GAD-7 scores from 10.6 to 6.0 (p < 0.01, Cohen's D = 1.03), and PSQI scores from 10.3 to 7.9 (p < 0.01, Cohen's D = 0.76). 38.6% (22 out of 57) of the participants achieved remission with significant improvement. Further analyses indicated that the presence of attitudinal barriers towards conventional psychological/psychiatric treatments and lower sleep disturbance scores at baseline increased the likelihood of achieving remission with significant improvement. The 4-week DEP-2306 intervention significantly alleviated symptoms of depression and anxiety, and improved sleep quality, suggesting a potential transdiagnostic outcome in DEIS. It was particularly responsive in individuals with attitudinal barriers and milder sleep disturbances at baseline. Trial Registration: This real-world study was retrospectively registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR2025000835) on April 24, 2025.

Keywords: Chinese herbal formula; anxiety; depressive episode with insufficient symptoms (DEIS); sleep; transdiagnostic effect.

FIGURE 1

Schematic representation of participants in the screening and interventions.

FIGURE 2

Effects of chinese herbal formula on sleep and mood outcomes. A linear mixed model was used to analyse the data. Bonferroni correction was applied in the analysis at baseline and at each visit. Error bars represent the 95% CIs of the estimated marginal means. *p < 0.05 compared to baseline; ^# p < 0.05 compared to Week 1; †p < 0.05 compared to Week 2. GAD‐7, generalized anxiety disorder 7‐item scale; HAMD‐17, hamilton rating scale for depression; PHQ‐9, patient health questionnaire‐9; PSQI, pittsburgh sleep quality index.